Adult patients treated in VA ECMO/Impella for cardiogenic shock/cardiac arrest undergoing PCI. Given the high incidence of bleeding from conventional antithrombotic therapy, the use of readily available and rapidly metabolized cangrelor should result in adequate efficacy and increased safety. Patients will receive scoagulation with bivalirudin (target apt 55-70 seconds) and cangrelor with starting dose 0.125 mcg/kg/min and adjusted with step +/- 0.125 mcg/kg/min.
Conditions
Brief summary
Efficacy and safety clinical endpoint will be the occurrence of thrombotic adverse events and bleeding adverse events, respectively, during the time of cangrelor infusion (see text for adverse events definition)., Safety primary endpoint will be the occurrence of major bleeding events. Major bleeding will be defined as: type 3b or 5 Bleeding Academic Research Consortium (BARC) bleeding.
Sponsors
Ospedale San Raffaele S.r.l.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy and safety clinical endpoint will be the occurrence of thrombotic adverse events and bleeding adverse events, respectively, during the time of cangrelor infusion (see text for adverse events definition)., Safety primary endpoint will be the occurrence of major bleeding events. Major bleeding will be defined as: type 3b or 5 Bleeding Academic Research Consortium (BARC) bleeding. | — |
Countries
Italy
Outcome results
None listed